Mela Sciences Announces First Quarter 2012 Financial Results

IRVINGTON, NY--(Marketwire - May 03, 2012) - MELA Sciences, Inc. (NASDAQ: MELA), the medical device company that has developed MelaFind®, today announced financial results for the first quarter ended March 31, 2012.

First Quarter 2012 Performance Highlights:

  • Commenced commercialization of MelaFind as part of a controlled and deliberate launch in the US, focusing on the Northeast, and in several key cities throughout Germany.

    • The Company is working with customers to train and assist them in using MelaFind appropriately and to incorporate its use successfully into their practices.

    • MELA Sciences presented MelaFind at the American Academy of Dermatology (AAD) Annual Meeting in San Diego which was held in late March. The Company collected over 200 leads, and reception from dermatologists has been encouraging.

  • Entered into a three-year expanded manufacturing agreement with its long-term supplier, Askion GmbH for the production of the MelaFind hand-held device.

    • Askion has built systems to support the initial launch of MelaFind and is currently building inventory for the early commercialization effort, ensuring a secure supply of MelaFind hand-held devices for the next three years.

  • Entered into a two-year agreement with Quintiles (Quintiles Commercial Germany GmbH) for commercialization support for MelaFind in Germany.

    • Quintiles is providing customer service, sales, marketing and management support to supplement the commercialization and launch of MelaFind in Germany.

"We are pleased to report the significant achievements we have reached in the first quarter of 2012, most notably our commercial launch of MelaFind into the US and Germany," said Dr. Joseph V. Gulfo, President and CEO of MELA Sciences. "While we are in the initial phase of our controlled and deliberate launch, MelaFind has been put into the offices of a handful of dermatologists in the US and Germany. Early experiences indicate great interest in MelaFind as we work with these dermatologists to help them incorporate it into their practices, which will, in turn, facilitate wider penetration."

"We look forward to participating in the NASDAQ Opening Bell ceremonies on Melanoma Monday (May 7, 2012), during which we will do our part to communicate the need for detecting melanoma at its earliest and most curable stages," Dr. Gulfo continued.

MelaFind is the Company's breakthrough non-invasive and objective automated point-of-care system for use when a dermatologist chooses to obtain additional information for a decision to biopsy clinically atypical pigmented skin lesions with one or more clinical or historical characteristics of melanoma.

First Quarter 2012 Financial Results
Revenues for the three months ended March 31, 2012 were $11,250 compared to no revenues reported for the same period in 2011.

The Company's net loss for the three months ended March 31, 2012 was $5.8 million, or $0.19 per diluted share, compared to a net loss of $4.9 million, or $0.20 per diluted share, for the same period in 2011. The increase in the net loss was primarily attributable to an increase in General and Administrative expenses related to incremental marketing costs as well as the expansion of the Company's sales force and the re-allocation of certain expenses from Research & Development to General and Administrative to properly reflect commercial operations.

As of March 31, 2012, the Company's cash and cash equivalents were $22.3 million.

Conference Call
MELA Sciences will host a conference call today at 4:30 PM ET to discuss first quarter 2012 quarterly results. To participate in the call, dial 1-888-437-9481 approximately 10 minutes before the conference call is scheduled to begin. To listen via live webcast, please go to the investor relations section of the MELA Sciences website at http://www.melasciences.com approximately 10 minutes prior to the teleconference start time. If you are unable to participate during the live conference call and webcast, the conference call audio cast will be archived and available for replay for approximately 90 days.

About MELA Sciences, Inc.
MELA Sciences is a medical device company focused on the commercialization of its flagship product, MelaFind®, and its further design and development. MelaFind is a non-invasive tool to provide additional information to dermatologists during melanoma skin examinations. The device uses light from visible to near-infrared wavelengths to evaluate skin lesions up to 2.5 mm beneath the skin. The device provides information on a lesion's level of morphologic disorganization to provide additional objective information that may be used by dermatologists in the biopsy decision-making process. MelaFind has been approved by the US Food and Drug Administration for use in the US. In addition, MelaFind has received CE Mark approval and is approved for use in the European Union.

For more information on MELA Sciences, visit www.melasciences.com.

Safe Harbor
This press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to our plans, objectives, expectations and intentions and other statements that contain words such as "expects," "contemplates," "anticipates," "plans," "intends," "believes," "assumes," "predicts" and variations of such words or similar expressions that predict or indicate future events or trends, or that do not relate to historical matters. These statements are based on our current beliefs or expectations and are inherently subject to significant known and unknown uncertainties and changes in circumstances, many of which are beyond our control. There can be no assurance that our beliefs or expectations will be achieved. Actual results may differ materially from our beliefs or expectations due to financial, economic, business, competitive, market, regulatory and political factors or conditions affecting the company and the medical device industry in general, as well as more specific risks and uncertainties facing the company such as those set forth in its reports on Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission (the "SEC"). Factors that might cause such a difference include whether MelaFind® achieves market acceptance. Given the uncertainties affecting companies in the medical device industry such as the Company, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. The Company urges you to carefully review and consider the disclosures found in its filings with the SEC which are available at www.sec.gov and www.melasciences.com.

                                                                            
                            MELA SCIENCES, INC.                             
                          CONDENSED BALANCE SHEETS                          
                                                                            
                                                 March 31,     December 31, 
                                                    2012           2011     
                                               -------------  ------------- 
                                                (unaudited)         *       
                    ASSETS                                                  
                                                                            
Current Assets:                                                             
Cash and cash equivalents                      $  22,301,266  $  27,996,871 
Accounts receivable                                   12,078                
Inventory                                            400,363                
Prepaid expenses and other current assets            816,206      1,061,550 
                                               -------------  ------------- 
Total Current Assets                              23,529,913     29,058,421 
Property and equipment, net                        2,411,815      1,626,791 
Patents and trademarks, net                           56,233         59,208 
Deferred financing costs                              62,391         62,391 
Other assets                                          64,484        586,498 
                                               -------------  ------------- 
Total Assets                                   $  26,124,836  $  31,393,309 
                                               =============  ============= 
                                                                            
     LIABILITIES AND STOCKHOLDERS' EQUITY                                   
                                                                            
Current Liabilities:                                                        
Accounts payable                               $     940,117  $     670,950 
Accrued expenses                                     551,978        745,754 
Deferred placement revenue                            17,250                
Other current liabilities                             44,880         30,993 
                                               -------------  ------------- 
Total Current Liabilities                          1,554,225      1,447,697 
                                               -------------  ------------- 
                                                                            
Long Term Liabilities:                                                      
Deferred rent                                        139,605        138,216 
                                               -------------  ------------- 
Total Long Term Liabilities                          139,605        138,216 
                                               -------------  ------------- 
Total Liabilities                                  1,693,830      1,585,913 
                                               -------------  ------------- 
                                                                            
 COMMITMENTS, CONTINGENCIES and LITIGATION                                  
                                                                            
Stockholders' Equity                                                        
Preferred stock -- $.10 par value; authorized                               
 10,000,000 shares; issued and outstanding:                                 
 none                                                                       
                                                                            
Common stock -- $.001 par value; authorized           30,332         30,308 
 45,000,000 shares; issued and outstanding                                  
 30,332,217 shares at March 31, 2012 and                                    
 30,307,538 at December 31, 2011                                            
Additional paid-in capital                       149,681,035    149,304,424 
Accumulated deficit                             (125,280,361)  (119,527,336)
                                               -------------  ------------- 
Stockholders' Equity                              24,431,006     29,807,396 
                                               -------------  ------------- 
Total Liabilities and Stockholders' Equity     $  26,124,836  $  31,393,309 
                                               -------------  ------------- 
                                                                            
                                                                            
* Derived from the audited balance sheet as of December 31, 2011        
                                                                        
                                                                            
                                                                            
                            MELA SCIENCES, INC.                             
                     CONDENSED STATEMENTS OF OPERATIONS                     
                                (unaudited)                                 
                                                                            
                                               Three months ended March 31, 
                                               ---------------------------- 
                                                    2012           2011     
                                               -------------  ------------- 
Revenue                                        $      11,250                
Cost of revenue                                      130,410                
                                               -------------                
Gross profit                                        (119,160)               
Operating expenses:                                                         
Research and development                       $   2,434,758  $   2,576,128 
General and administrative                         3,217,491      2,393,120 
                                               -------------  ------------- 
Operating loss                                    (5,771,409)    (4,969,248)
Interest income                                       13,384         20,531 
Other income, net                                      5,000          6,648 
                                               -------------  ------------- 
Net loss                                       $  (5,753,025) $  (4,942,069)
                                               =============  ============= 
                                                                            
Basic and diluted net loss per common share    $       (0.19) $       (0.20)
                                               =============  ============= 
                                                                            
Basic and diluted weighted average number of                                
 common shares outstanding                        30,313,905     25,262,538 
                                               =============  ============= 
                                                                            
                                                                            
                                                                            
                            MELA SCIENCES, INC.                             
                     CONDENSED STATEMENTS OF CASH FLOWS                     
                                (unaudited)                                 
                                                                            
                                               Three Months Ended March 31, 
                                               ---------------------------- 
                                                    2012           2011     
                                               -------------  ------------- 
Cash flows from operating activities:                                       
  Net loss                                     $  (5,753,025) $  (4,942,069)
  Adjustments to reconcile net loss to net                                  
   cash used in operating activities:                                       
    Depreciation and amortization                    148,044        147,086 
    Noncash compensation                             347,618        170,646 
    Changes in operating assets and                                         
     liabilities:                                                           
      Increase in accounts receivable                (12,078)             - 
      Increase in inventory                         (310,090)             - 
      Decrease in prepaid expenses and other                                
       current assets                                155,071        156,014 
      Increase (decrease) in accounts payable                               
       and accrued expenses                           75,391        (19,243)
      Increase in deferred rent                        1,389          8,478 
      Increase in deferred placement revenue          17,250              - 
      Increase in other current liabilities           13,887          7,093 
                                               -------------  ------------- 
        Net cash used in operating activities     (5,316,543)    (4,471,995)
                                               -------------  ------------- 
Cash flows from investing activities:                                       
  Purchases of property and equipment               (408,079)        (7,645)
                                               -------------  ------------- 
        Net cash used in investing activities       (408,079)        (7,645)
                                               -------------  ------------- 
Cash flows from financing activities:                                       
  Proceeds from exercise of stock options             33,310              - 
  Expenses related to 2011 Public Offering            (4,293)             - 
                                               -------------  ------------- 
        Net cash provided by financing                                      
         activities                                   29,017              - 
                                               -------------  ------------- 
Net decrease in cash and cash equivalents         (5,695,605)    (4,479,640)
Cash and cash equivalents at beginning of                                   
 period                                           27,996,871     30,520,812 
                                               -------------  ------------- 
Cash and cash equivalents at end of period     $  22,301,266  $  26,041,172 
                                               =============  ============= 
                                                                            
Supplemental disclosure of cash flow                                        
 information:                                                               
Non-cash investing activity:                                                
Reclassification of MelaFind® components                                  
 from other assets to property and equipment   $     522,014              - 

For further information contact:

For Investors
Lynn Pieper
Westwicke Partners
415-202-5678

For Media
Melissa Hurley
Ricochet Public Relations
212-679-3300 x128

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